Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-31 @ 12:40 AM
Study NCT ID:
NCT05664204
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Veno-arterial ExtraCorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung TransPlant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015199', 'term': 'Extracorporeal Membrane Oxygenation'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-09-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-16', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of ventilator-free days', 'timeFrame': 'The 28 days following LT', 'description': 'Assess the efficacy of a systematic, pre-operative VA-ECMO strategy on increasing ventilator-free days in the 28 days following LT'}], 'secondaryOutcomes': [{'measure': 'The occurrence of grade III PGD', 'timeFrame': 'The 72 hours following LT'}, {'measure': 'All-cause mortality', 'timeFrame': 'Day-90 after LT'}, {'measure': 'Vital status', 'timeFrame': 'Day-90 after LT'}, {'measure': 'Time-to-death from all causes', 'timeFrame': 'The first year after LT'}, {'measure': 'The occurrence of ECMO-associated adverse event ; ECMO-associated adverse event defined as cannula infection, misplacement, intra-operative or per-ECMO air-embolism, limb ischemia, vascular complications, thrombophlebitis', 'timeFrame': 'The 28 days following LT, Assessed daily from day-1 to day-90'}, {'measure': 'The occurrence of ventilator associated pneumonia (VAP) ; Occurrence of VAP (microbiologically confirmed pneumonia occurring under invasive ventilation 21 and after 48 hours of invasive ventilation)', 'timeFrame': 'The 28 days following LT'}, {'measure': 'The occurrence of intraoperative hemodynamic failure;', 'timeFrame': 'The 28 days following LT', 'description': 'Intra-operative amount of norepinephrine (dose in microg/kg of body weight)'}, {'measure': 'The occurrence of post-operative hemodynamic failure ;', 'timeFrame': 'The 28 days following LT', 'description': 'Norepinephrine-free days (number of days without noradrenaline administration)'}, {'measure': 'The occurrence of acute renal failure;', 'timeFrame': 'The 28 days following LT', 'description': 'Renal failure KDIGO stage 3'}, {'measure': 'The need of red blood cell transfusion', 'timeFrame': 'The 28 days following LT', 'description': 'Number of red blood cell packs administered'}, {'measure': 'ECMO-free days ; VV or VA-ECMO-free days', 'timeFrame': 'The 28 days following LT'}, {'measure': 'The length of intensive care unit stay', 'timeFrame': 'at day 90', 'description': 'Length of ICU stay in days'}, {'measure': 'The length of hospital stay; Length of hospital stay in days', 'timeFrame': 'at day 90'}, {'measure': 'The occurrence of bronchial complication requiring a bronchoscopic intervention ; Bronchial complications requiring a bronchoscopic intervention', 'timeFrame': 'From LT to 1-year'}, {'measure': 'Forced expiratory volume during the first second (FEV1)', 'timeFrame': 'At 1-year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Number of Ventilator-free Days in the 28 Days Following LT']}, 'referencesModule': {'references': [{'pmid': '38448059', 'type': 'DERIVED', 'citation': "Messika J, Eloy P, Boulate D, Charvet A, Fessler J, Jougon J, Lacoste P, Mercier O, Portran P, Roze H, Sage E, Thes J, Tronc F, Vourc'h M, Montravers P, Castier Y, Mal H, Mordant P; Investigators from the ECMOToP Study group. Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial. BMJ Open. 2024 Mar 5;14(3):e077770. doi: 10.1136/bmjopen-2023-077770."}]}, 'descriptionModule': {'briefSummary': 'In patients undergoing lung transplantation (LT), the investigators hypothesize that a "systematic" intraoperative ECMO strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events, as compared to an "on-demand" intraoperative ECMO strategy.\n\nTo date, LT remains a highly hazardous procedure. Even if the surgical procedure is well established, the intraoperative support is not, and most intra-operative ECMO decisions rely on local protocols, anesthesiologists\' habits, and surgeons\' preference.\n\nThe efficacy of applying a "systematic" strategy on reducing the occurrence of severe primary graft dysfunction and thus mechanical ventilation in the 28 days following LT, without increasing mortality or morbidity, would support future guidelines on the use of ECMO in the intraoperative period of LT for obstructive and restrictive lung diseases.', 'detailedDescription': 'Lung transplantation (LT) provides the prospect of improved survival and quality of life for patients with end stage lung and pulmonary vascular diseases. Its performance carries significant adverse effects, being either intra- or postoperative. The ventilation of a diseased lung for sometimes extended periods and the risk of reperfusion oedema and primary graft dysfunction is a challenge. Moreover, significant hemodynamic instabilities episodes might occur, because of pressure on, or displacement of the heart, clamping of the pulmonary arteries and ischemia-reperfusion syndrome. veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has now replaced cardiopulmonary bypass for respiratory and hemodynamic intraoperative support, carrying less side effects, and an improved early survival.\n\nEven though ECMO is a widely used technique, no precise guideline exists on the hemodynamic and respiratory indexes in LT settings to initiate intraoperative ECMO, but only experts\' opinion. Besides, it has to be underlined that the rate of LT performed in the absence of any mechanical support is highly variable among centres, ranging from being exceptional up to 70%.\n\nThe investigators aim at evaluating two strategies of ECMO initiation in the pre- and intraoperative periods in patients with pulmonary disease requiring LT: an "on-demand" strategy, in which VA-ECMO will be initiated on high hemodynamic and respiratory needs thresholds and a "systematic" strategy in which VA-ECMO will be pre-emptively initiated.\n\nThe investigators hypothesize that a "systematic" strategy allows to reduce the risk of severe primary graft dysfunction and the need for mechanical ventilator in the 28 days following LT without increasing adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\>18 years Assessed for bilateral sequential lung transplantation for obstructive or restrictive lung disease Affiliation to the French social security Written informed consent\n\nExclusion Criteria:\n\nAt listing :\n\n* a pulmonary hypertension with a mPAP \\> 45 mmHg, including in the absence of haemodynamic collapse (MAP, LVEF, RV function all normal)\n* a pulmonary hypertension with echocardiographic evidences of right heart dysfunction (paradoxical septum or RV dilatation or RVEF \\< 35%)\n* a pre-capillary pulmonary hypertension at right heart catheterization with low cardiac output\n\n * LT for primary pulmonary hypertension\n * LT for cystic fibrosis and graft-vs-host disease\n * Re-do LT\n * Combined multi-organ transplantation\n * Active malignancy\n * Pregnancy, breastfeeding\n * Patients under guardianship (tutelle, curatelle, sauvegarde de justice)\n\nSocondary exclusion criteria:\n\nPatients without pulmonary hypertension or with pulmonary hypertension without right ventricular dilatation on an echocardiography in the last 6 months will be randomized; Patients meeting one of the following criteria will not be randomized and will be secondary excluded from the study :\n\n* preoperative severe pulmonary hypertension with hemodynamic collapse on echocardiography defined by: paradoxical septum or dilatation of the right ventricle or RVEF \\< 20LT in a patient under ECMO as bridge-to-transplantation\n* PreLT hypoxemia with PaO2/FiO2 \\< 80mmHg\n* PreLT hypercapnia PaCO2 \\> 80 mmHg after induction'}, 'identificationModule': {'nctId': 'NCT05664204', 'acronym': 'ECMOToP', 'briefTitle': 'Veno-arterial ExtraCorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung TransPlant', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Veno-arterial Extracorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung Transplant: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'APHP211037'}, 'secondaryIdInfos': [{'id': '2022-A00538-35', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Systematic ECMO', 'description': 'VA-ECMO will be implanted before the first pulmonary artery cross-clamp, in a systematic manner', 'interventionNames': ['Procedure: Veno-arterial extracorporeal membrane oxygenation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'On-demand ECMO', 'description': 'VA-ECMO will be implanted intraoperatively, in an unplanned manner if the hemodynamic and respiratory indices meet pre-planned criteria at different time-points:\n\na PaO2/FiO2 ratio\\<100 mmHg or a respiratory acidosis, with pH\\< 7.2, PaCO2\\>60 mmHg, a mean pulmonary arterial pressure\\>50mmHg (or 2/3 of MAP) and/or an acute pulmonal core at trans-esophageal echography monitoring an acute left ventricular dysfunction at trans-esophageal echography monitoring', 'interventionNames': ['Procedure: Veno-arterial extracorporeal membrane oxygenation']}], 'interventions': [{'name': 'Veno-arterial extracorporeal membrane oxygenation', 'type': 'PROCEDURE', 'description': 'Strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events', 'armGroupLabels': ['On-demand ECMO', 'Systematic ECMO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hôpital Bichat Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92 150', 'city': 'Suresnes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jonathan MESSIKA, MD', 'role': 'CONTACT', 'email': 'j.messika@hopital-foch.com', 'phone': '+33 1 46 25 59 84'}], 'facility': 'Hôpital FOCH', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'centralContacts': [{'name': 'Jonathan MESSIKA, MD', 'role': 'CONTACT', 'email': 'j.messika@hopital-foch.com', 'phone': '+33 1 46 25 59 84'}], 'overallOfficials': [{'name': 'Jonathan MESSIKA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital FOCH'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Up to two years after the last publication of the research results', 'ipdSharing': 'YES', 'description': 'participant-level deidentified dataset', 'accessCriteria': 'IPD and any additional supporting information will be available on reasonable request from the corresponding author, for additional analyses such as -but not limited to- metaanalyses. The scientific advisory board of ECMOTOP study will assess the relevance of the request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}